MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number ROTAFLOW DRIVE UNIT, BLUE

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information regarding the failure and the repair of the device have been requested, but not yet received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that the closing assy on the rotaflow drive was broken.The closing assy was in place by tape by customer.The rotaflow drive is currently connected to a patient.No indication of actual or potential for harm or death has been reported.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in france.It was reported that the closing assy on the rotaflow drive was broken during use.The customer wanted to put cream back and the force was too excessive therefore the part was broken.The customer reacted very quickly and the closing assy was in place by tape by customer.No harm to the patient has been reported.The affected rotaflow drive (rfd) with s/n (b)(6) was investigated by a getinge field service technician after the treatment and the reported failure "closing assy broken" could be confirmed.As stated by the technician the root cause could be determined as too excessive force by the customer during put in new contact cream in the rotaflow drive.The closing assy was replaced by the technician.However, in addition to the reported excessive force, according to the previous investigation of a similar complaint by our life cycle engineering (lce, product specialists) the following contributing factors cannot be excluded: weaking due to manufacturing errors (air inclusions) weaking due to aging.Uv light (sun) or contact with chemicals.The review of the non-conformities was performed on 2021-04-27 during the period of 2014-05-01 to 2021-04-27 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The product in question was produced in 2014-05-01.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11751283
• MDR Text Key: 248178517
• Report Number: 8010762-2021-00278
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2021
• Patient Sequence Number: 1